Recruiting

Phase 1

ElranatamabHEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV

Sponsor:

University of Illinois at Chicago

Code:

NCT07647432

Conditions

Plasmablastic Lymphoma

HIV

Consolidation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elranatamab (Elra)

Study Details

Brief summary:

This is a single-arm feasibility trial in which patients with histologically confirmed plasmablastic lymphoma (PBL) with or without HIV, who have achieved a Complete Response or Partial Response after definitive frontline chemotherapy, will receive Elranatamab (Elra) consolidation.

Conditions

Plasmablastic Lymphoma

HIV

Consolidation

Study ID

NCT07647432

Start date

Oct 21, 2026

Status verified date

Oct, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age ≥ 18 years at time of consent
ECOG PS 0 or 1
Histologically and immunophenotypically confirmed PBL
Ann Arbor stage at initial diagnosis: stage I with LDH > ULN and/or bulky disease >7.5 cm or stage II-IV
Received definitive front-line therapy for PBL with end-of-treatment PR or CR. Date of end-of-treatment response evaluation must be within 8 weeks prior to enrollment.
Adequate bone marrow function with recovery from prior therapy (without growth factor or transfusion support), defined as:

ANC ≥ 500 cells/mcL
Platelet count ≥ 50,000 cells/mcL
Hemoglobin ≥8 g/dL
Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
Adequate hepatic function characterized by the following:

Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert's syndrome)
AST ≤2.5 x ULN
ALT ≤2.5 x ULN
Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.
Able to provide written informed consent and HIPAA authorization for release of personal health information via an approved UIC IRB ICF and HIPAA authorization. If a subject is unable to consent, an LAR may provide consent on their behalf.
As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study
If capable of becoming pregnant: Negative serum or urine pregnancy test
If HIV-positive:

Receiving effective combined antiretroviral therapy
CD4+ T-cell count ≥ 50 cells/mcL within 4 weeks before enrollment

Exclusion criteria:

Prior BCMA bispecific therapy
Stable or progressive disease following front-line therapy as determined by the investigator
Receiving any other investigational agents
Expected survival < 2 months
Known or suspected PBL involvement of the parenchymal brain or spinal cord at diagnosis. Asymptomatic leptomeningeal disease only will be allowed.
Uncontrolled intercurrent illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Concurrent malignancy requiring active therapy within the last 3 years, except for the following:

Basal cell carcinoma limited to the skin
Squamous cell carcinoma limited to the skin
Carcinoma in situ of the cervix or breast
Adequately treated lentigo malignant melanoma
Localized prostate cancer
Active therapy consists of adjuvant or maintenance therapy to reduce the risk of recurrence of a malignancy that was previously treated with curative intent and with no evidence of active disease within 2 years prior to screening
Pregnant or nursing
PWH with a history of AIDS-defining opportunistic infection within the past year
Receipt of a live vaccine within 28 days prior to the first dose of study treatment

Study Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-arm Open label study of Elra of pts with PBL

Patients will receive Elra subcutaneously for up to six 28-day cycles, beginning with a step-up dosing schedule (12 mg on day 1, 32 mg on day 4, followed by 76 mg weekly on days 8, 15, and 22 of Cycle 1). Patients will transition to 76 mg every 2 weeks (days 1 and 15) during Cycles 2 and 3, followed by an interim PET/CT assessment at the end of Cycle 3. During Cycles 4 through 6, all patients will receive 76 mg every 4 weeks (on day 1 of each cycle).

Interventions

Elranatamab (Elra)

Elra will be administered subcutaneously on day 1, day 4, then weekly on day 8, 15 and day 22 completing 1 cycle. Up to 6 cycles may be given.

Primary outcome measure

Feasibility of giving Elra in consolidation after therapy of PBL [ Time Frame: 12 weeks ( 3 cycles) ]
Estimate the complete response in HIV+/ HIV- patients [ Time Frame: 6 months ]
Evaluate the safety and tolerability of Elra consolidation [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Paul Rubinstein, MD

312 413 1300 paulgr@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Meredith Russell, BS

312-355-5112 mrussel3@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.